Trial Outcomes & Findings for Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment (NCT NCT02155946)
NCT ID: NCT02155946
Last Updated: 2023-11-30
Results Overview
Raw number of face-name pairs correctly recalled with a maximum of 15 points; higher values are better at each time point. Change at post-session 5 (day 5 after baseline)) calculated relative to baseline performance (positive differences indicate improvement; negative values indicate decline). Data coding errors were identified and accurate values were reported 2/6/2023.
COMPLETED
NA
107 participants
change from baseline to post session 5 (day 5 after baseline)
2023-11-30
Participant Flow
Participant milestones
| Measure |
Arm 1
Group receives active brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 2
Group receives sham brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
Arm 3
Group receives active brain stimulation plus autobiographical recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 4
Group receives sham brain stimulation plus autobiographical recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
25
|
29
|
24
|
|
Overall Study
COMPLETED
|
29
|
23
|
29
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment
Baseline characteristics by cohort
| Measure |
Arm 1
n=29 Participants
Group receives active brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 2
n=25 Participants
Group receives sham brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
Arm 3
n=29 Participants
Group receives active brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 4
n=24 Participants
Group receives sham brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
72.59 Years
STANDARD_DEVIATION 7.31 • n=5 Participants
|
73.88 Years
STANDARD_DEVIATION 6.08 • n=7 Participants
|
72.31 Years
STANDARD_DEVIATION 7.36 • n=5 Participants
|
74.04 Years
STANDARD_DEVIATION 6.2 • n=4 Participants
|
73.14 Years
STANDARD_DEVIATION 6.76 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: change from baseline to post session 5 (day 5 after baseline)Population: Patient-level factors of age, sex, race, RBANS Delayed Memory Index, MoCA, Emory version of the Wisconsin Card Sorting Test were included as covariates.
Raw number of face-name pairs correctly recalled with a maximum of 15 points; higher values are better at each time point. Change at post-session 5 (day 5 after baseline)) calculated relative to baseline performance (positive differences indicate improvement; negative values indicate decline). Data coding errors were identified and accurate values were reported 2/6/2023.
Outcome measures
| Measure |
Arm 1
n=29 Participants
Group receives active brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 2
n=23 Participants
Group receives sham brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
Arm 3
n=29 Participants
Group receives active brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 4
n=24 Participants
Group receives sham brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
|---|---|---|---|---|
|
Face-name Memory Test Performance
|
-.28 pairs correctly recalled/recognized
Interval -1.29 to 0.74
|
-.01 pairs correctly recalled/recognized
Interval -1.15 to 1.13
|
-1.29 pairs correctly recalled/recognized
Interval -2.33 to -0.24
|
-1.76 pairs correctly recalled/recognized
Interval -2.86 to -0.66
|
PRIMARY outcome
Timeframe: change from baseline to post session 5 (day 5 after baseline)Population: Patient-level factors of age, sex, race, RBANS Delayed Memory Index, MoCA, Emory version of the Wisconsin Card Sorting Test were included as covariates.
Performance measured using number of correctly identified locations (3 locations per stimulus; 15 total stimuli). Higher values indicate better performance. Change at post-session 5 (day 5 after baseline) calculated relative to baseline performance (positive differences indicate improvement; negative values indicate decline). Data coding errors were identified and accurate data were updated 2/6/2023.
Outcome measures
| Measure |
Arm 1
n=29 Participants
Group receives active brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 2
n=23 Participants
Group receives sham brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
Arm 3
n=29 Participants
Group receives active brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 4
n=24 Participants
Group receives sham brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
|---|---|---|---|---|
|
Object Location Association Memory Test Performance - Recognition Condition
|
.55 Number correct relative to baseline
Interval -0.48 to 1.58
|
.25 Number correct relative to baseline
Interval -0.9 to 1.4
|
.07 Number correct relative to baseline
Interval -0.98 to 1.12
|
-.76 Number correct relative to baseline
Interval -1.87 to 0.35
|
PRIMARY outcome
Timeframe: change from baseline to post session 5 (day 5 after baseline)Changes in task related blood oxygen dependent signal (BOLD) activation for the face-name (novel post \> novel pre) contrast in the left inferior frontal gyrus (pars triangularis, pars orbitalis, pars opercularis). Data are preliminary betaweights for the above noted contrast. Positive values reflect increased BOLD signal while negative values represent reduced BOLD signal. Not all participants were able to complete fMRI, which explains sample size discrepancies with other outcome measures. Data coding errors were discovered and accurate, updated data reported on 2/6/2023
Outcome measures
| Measure |
Arm 1
n=23 Participants
Group receives active brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 2
n=21 Participants
Group receives sham brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
Arm 3
n=20 Participants
Group receives active brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 4
n=20 Participants
Group receives sham brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
|---|---|---|---|---|
|
fMRI Betaweight Change
|
.34 Percent BOLD signal change
Interval 0.08 to 0.59
|
-.09 Percent BOLD signal change
Interval -0.36 to 0.18
|
.07 Percent BOLD signal change
Interval -0.22 to 0.35
|
-.13 Percent BOLD signal change
Interval -0.39 to 0.13
|
SECONDARY outcome
Timeframe: change from baseline to post Session 5 (day 5 after baseline)Performance on the Ecological Memory Simulations- Medical Instructions subtest. Raw points where higher values reflect better performance at each time point (0-15 possible points at each time point). Reported values reflect change from baseline (i.e., post-session day 5 vs. baseline) where positive values represent improvement and negative values represent decline. Corrected values are now included (2/23) that account for age, sex, and baseline neuropsychological abilities.
Outcome measures
| Measure |
Arm 1
n=29 Participants
Group receives active brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 2
n=23 Participants
Group receives sham brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
Arm 3
n=29 Participants
Group receives active brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 4
n=24 Participants
Group receives sham brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
|---|---|---|---|---|
|
Prose Memory
|
-1.07 units on a scale
Interval -2.23 to 0.1
|
-1.18 units on a scale
Interval -2.46 to 0.11
|
-.93 units on a scale
Interval -2.13 to 0.26
|
-1.56 units on a scale
Interval -2.81 to -0.31
|
SECONDARY outcome
Timeframe: change from baseline to post session 5 (day 5 after baseline)Changes on the Multifactorial Memory Questionnaire - strategy subscale. Raw points where higher values reflect better performance at each time point (0-76 possible points at each time point). Reported values reflect change from baseline (i.e., post-session day 5 vs. baseline) where positive values represent improvement and negative values represent decline.
Outcome measures
| Measure |
Arm 1
n=29 Participants
Group receives active brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 2
n=23 Participants
Group receives sham brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
Arm 3
n=29 Participants
Group receives active brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 4
n=24 Participants
Group receives sham brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
|---|---|---|---|---|
|
MMQ - Strategy Subscale
|
1.41 units on a scale
Interval -0.97 to 3.8
|
1.1 units on a scale
Interval -1.6 to 3.81
|
-1.9 units on a scale
Interval -4.28 to 0.48
|
-.5 units on a scale
Interval -3.12 to 2.12
|
SECONDARY outcome
Timeframe: change from baseline to post session 5 (day 5 after baseline)Performance on Ecological Memory Simulations routes subtest (serial order). Higher values indicate better performance at each time point (0-9 possible points at each time point). Change from baseline is reported (post-session day 5 vs. baseline) so higher values indicate better recall while negative values indicate decline. Corrected data are now reported (2/23) accounting for age, sex, and baseline neuropsychological abilities.
Outcome measures
| Measure |
Arm 1
n=29 Participants
Group receives active brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 2
n=23 Participants
Group receives sham brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
Arm 3
n=29 Participants
Group receives active brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 4
n=24 Participants
Group receives sham brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
|---|---|---|---|---|
|
Spatial Navigation
|
.59 units on a scale
Interval -0.15 to 1.32
|
.74 units on a scale
Interval -0.08 to 1.55
|
1.03 units on a scale
Interval 0.27 to 1.79
|
.6 units on a scale
Interval -0.19 to 1.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: change from baseline post treatment (within ~ 96 hours of session 5)Population: linear mixed model Data analyzed using a composite "recognition" total score that combined the face-name and object-location task (change on 0-30 point scale relative to baseline) higher scores are better). Patient-level factors of age, sex, race, RBANS Delayed Memory Index, MoCA, Emory version of the Wisconsin Card Sorting Test (total sorts) were included as covariates.
Planned analyses to examine patient specific characteristics that affect treatment efficacy and would be vital for clinical translation at the individual patient level. Data analyzed using a composite "recognition" score that combined the face-name and object-location task recognition scores (total on a 0-30 point scale; values below are change from baseline; higher values are "better" and reflect improved memory test performance). Patient-level factors of age, sex, race, RBANS Delayed Memory Index, MoCA, Emory version of the Wisconsin Card Sorting Test (total sorts) were included as covariates.
Outcome measures
| Measure |
Arm 1
n=29 Participants
Group receives active brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 2
n=23 Participants
Group receives sham brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
Arm 3
n=29 Participants
Group receives active brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 4
n=24 Participants
Group receives sham brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
|---|---|---|---|---|
|
Planned (Tertiary) Analyses of Patient-specific Characteristics That Affect Treatment Outcome
|
.28 change in total score on 30 point scale
Interval -1.23 to 1.79
|
.09 change in total score on 30 point scale
Interval -1.62 to 1.79
|
-1.12 change in total score on 30 point scale
Interval -2.68 to 0.43
|
-2.52 change in total score on 30 point scale
Interval -4.15 to -0.89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Betaweight change: Post session 5 (day 5) minus baselinePopulation: linear mixed model that includes EF as a predictor variable as well as covariates of age, sex, education, and race.
Outcome measure is the change in betaweight (as a percent signal change: post session 5 minus baseline) during the face-name and object-location tasks (same metric as Primary Outcome measure 3) while controlling for the electric field (EF). Finite element model based measurement of electric field in the targeted brain regions (Values range from 0 to no theoretical upper limit with higher values reflecting more electrical current; most values will be under 0.5 V/m). The EF was calculated using the baseline MRI T1 scan for each individual. EF values were then included in the linear mixed model analysis of fMRI Beta-weight change (post training vs. baseline) since EF values at the targeted brain region varied across participants. Note, EF values only apply to active HD-tDCS groups, so sham groups have no data to report and were removed accordingly (updated 2/23).
Outcome measures
| Measure |
Arm 1
n=23 Participants
Group receives active brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 2
n=20 Participants
Group receives sham brain stimulation plus mnemonic strategy training
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
Arm 3
Group receives active brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Active brain stimulation
|
Arm 4
Group receives sham brain stimulation plus autobiographical memory recall
Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit: Sham (placebo)
|
|---|---|---|---|---|
|
Change in Beta-weights Controlling for Electric Field (EF)
|
.11 % signal change (session 5 vs baseline)
Interval -0.08 to 0.3
|
-.03 % signal change (session 5 vs baseline)
Interval -0.22 to 0.16
|
—
|
—
|
Adverse Events
Arm 1
Arm 2
Arm 3
Arm 4
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place